The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.
Study Type
OBSERVATIONAL
Enrollment
18
Suspicious oral lesions will be identified by oral examination with incandescent light.
OralID uses a proven, optically based fluorescence technology that provides the clinician an aid in visualization of oral cancer, pre-cancer and other abnormal lesions.
Tissue will be collected to identify pre-cancerous or cancerous cells
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
Time frame: day 1 (at the time of oral examination)
Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV
Time frame: day 1 (at the time of oral examination)
Number of participants for whom biopsy results, but not CytID results, indicate presence of malignant or premalignant oral lesions
Time frame: day 1 (at the time of oral examination)
Number of participants for whom CytID results, but not biopsy results, indicate presence of malignant or premalignant oral lesions
Time frame: day 1 (at the time of oral examination)
Number of participants for whom biopsy does not indicate presence of malignant or premalignant oral lesions, but hpvID indicates presence of HPV
Time frame: day 1 (at the time of oral examination)
Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions, but hpvID does not indicate presence of HPV
Time frame: day 1 (at the time of oral examination)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CytID™ is an adjunctive process that is a noninvasive, pain-free, chair-side procedure for assessment of suspicious oral cavity lesions using a brush swab. The test is based on an objective measure of gross changes in the nuclear DNA content of oral epithelial cells; thereby, providing information about the pre-cancerous or cancerous state of a lesion.
hpvID™ testing can detect all major HPV types and shows the current HPV status of the patient. This provides additional clinical information to correlate and compare hpvID™ trends with routine standard of care biopsy or cytology results.